Investigation of a bone substitute for treating bone defects

A Post-market Clinical Follow-up Investigation to Confirm the Performance and Safety of the Bone Substitute b.Bone in Extremities and Pelvis.

This study is testing a new bone substitute called b.Bone to see if it helps patients heal from bone defects after surgery.

Quick facts

• Study type: Observational
• Enrollment: 135 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GreenBone Ortho S.p.A. (Industry-sponsored)
• Locations: 4 sites (Berlin and 3 other locations)
• Trial ID: NCT06156904 on ClinicalTrials.gov

What this trial studies

This observational clinical follow-up investigation aims to confirm the performance and safety of the bone substitute b.Bone after its implantation in patients with surgically created bone defects or those resulting from traumatic injuries. The study involves a multicenter, international approach where patients will undergo orthopedic surgery using b.Bone as part of their treatment. Participants will be evaluated preoperatively and at various time points post-surgery, including 3, 6, 12, and potentially up to 24 months for longer follow-up. The study will collect safety data throughout the process to assess the effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older undergoing standard bone grafting procedures for bone defects in the pelvis or extremities.

Not a fit: Patients with contraindications for b.Bone or those currently involved in conflicting clinical studies may not benefit from this investigation.

Why it matters

Potential benefit: If successful, this investigation could enhance healing outcomes for patients with significant bone defects.

How similar studies have performed: Other studies have shown promise with similar bone grafting approaches, suggesting potential for success in this investigation.

Eligibility criteria

Inclusion Criteria:

1. Patient is undergoing a standard of care bone grafting with b.Bone for the treatment of surgically created bone defects or bone defects resulting from traumatic injury in the extremities and pelvis according to the approved IFU.
2. Male or female patient ≥ 18 years old.
3. Patients willing and able to attend the standard of care follow-up visits and procedures.
4. Patients who have provided consent to participate in the clinical investigation and to the processing of personal data.

Exclusion Criteria:

1. Patients with any conditions in which b.Bone is not indicated according to the contraindications defined in the IFU of b.Bone
2. Patients who are currently enrolled in another clinical investigation/study that would directly interfere with the current clinical investigation, except when the patient is participating in a purely observational study with no associated treatments.
3. Woman who is pregnant or breast-feeding.
4. Patients who, in the opinion of the Investigator, have an existing condition that could affect their ability to complete patient reported questionnaires or be compliant with the standard of care follow-up visits and examinations for the duration of the clinical investigation.

Where this trial is running

Berlin and 3 other locations

• BG Klinikum Unfallkrankenhaus Berlin — Berlin, Germany (Recruiting)
• Trauma Surgery Department - University Hospital Regensburg — Regensburg, Germany (Recruiting)
• Hull University Teaching Hospitals NHS Trust — Hull, United Kingdom (Recruiting)
• Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary — Leeds, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Volker Alt, Dr — Director of the Trauma Surgery Department University Hospital Regensburg, Germany
• Study coordinator: Sonia Granados, MSc

Conditions Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury